consistently [1%:<1%, and were considered relevant: Application Site Reactions injection site pain Cardiovascular System vasovagal reaction, syncope, postural hypotension, non-specific ECG abnormalities Female Reproductive poor progression of labor, uterine atony Gastrointestinal System fecal incontinence, tenesmus, neonatal vomiting General and Other Disorders hypothermia, malaise, asthenia, accident and/or injury Hearing and Vestibular tinnitus, hearing abnormalities Heart Rate and Rhythm extrasystoles, non-specific arrhythmias, atrial fibrillation Liver and Biliary System jaundice Metabolic Disorders hypomagnesemia Musculoskeletal System myalgia Myo/Endo/Pericardium ST segment changes, myocardial infarction Nervous System tremor, Horner s syndrome, paresis, dyskinesia, neuropathy, vertigo, coma, convulsion, hypokinesia, hypotonia, ptosis, stupor Psychiatric Disorders agitation, confusion, somnolence, nervousness, amnesia, hallucination, emotional lability, insomnia, nightmares Respiratory System bronchospasm, coughing Skin Disorders rash, urticaria Urinary System Disorders urinary incontinence, micturition disorder Vascular deep vein thrombosis, phlebitis, pulmonary embolism Vision vision abnormalities For the indication epidural anesthesia for surgery, the 15 most common adverse events were compared between different concentrations of ropivacaine hydrochloride and bupivacaine. Table 4 is based on data from trials in the U.S. and other countries where ropivacaine hydrochloride was administered as an epidural anesthetic for surgery. Table 4 Common Events (Epidural Administration) Adverse Reaction Ropivacaine Hydrochloride Bupivacaine 5 mg/mL total N=256 7.5 mg/mL total N=297 10 mg/mL total N=207 5 mg/mL total N=236 7.5 mg/mL total N=174 N (%) N (%) N (%) N (%) N (%) hypotension 99 (38.7) 146 (49.2) 113 (54.6) 91 (38.6) 89 (51.1) nausea 34 (13.3) 68 (22.9) 41 (17.4) 36 (20.7) bradycardia 29 (11.3) 58 (19.5) 40 (19.3) 32 (13.6) 25 (14.4) back pain 18 (7) 23 (7.7) 34 (16.4) 21 (8.9) 23 (13.2) vomiting 18 (7) 33 (11.1) 23 (11.1) 19 (8.1) 14 (8) headache 12 (4.7) 20 (6.7) 16 (7.7) 13 (5.5) 9 (5.2) fever 8 (3.1) 5 (1.7) 18 (8.7) 11 (4.7) chills 6 (2.3) 7 (2.4) 6 (2.9) 4 (1.7) 3 (1.7) urinary retention 5 (2) 8 (2.7) 10 (4.8) 10 (4.2) paresthesia 5 (2) 10 (3.4) 5 (2.4) 7 (3) pruritus 14 (4.7) 3 (1.4) 7 (4) Using data from the same studies, the number (%) of patients experiencing hypotension is displayed by patient age, drug and concentration in Table 5. In Table 6, the adverse events for ropivacaine hydrochloride are broken down by gender. Table 5 Effects of Age on Hypotension (Epidural Administration) Total N: Ropivacaine Hydrochloride = 760, Bupivacaine = 410 AGE Ropivacaine Hydrochloride Bupivacaine 5 mg/mL 7.5 mg/mL 10 mg/mL 5 mg/mL 7.5 mg/mL N (%) N (%) N (%) N (%) N (%)> <65 68 (32.2) 99 (43.2) 87 (51.5) 64 (33.5) 73 (48.3) 65 31 (68.9) 47 (69.1) 26 (68.4) 27 (60) 16 (69.6) Table 6 Most Common Adverse Events by Gender (Epidural Administration) Total N: Females = 405, Males = 355 Adverse Reaction Female Male N (%) N (%) hypotension 220 (54.3) 138 (38.9) nausea 119 (29.4) 23 (6.5) bradycardia 65 (16) 56 (15.8) vomiting 59 (14.6) 8 (2.3) back pain 41 (10.1) 23 (6.5) headache 33 (8.1) 17 (4.8) chills 18 (4.4) 5 (1.4) fever 16 (4) 3 (0.8) pruritus 16 (4) 1 (0.3) pain 12 (3) 4 (1.1) urinary retention 11 (2.7) 7 (2) dizziness 9 (2.2) 4 (1.1) hypoesthesia 8 (2) 2 (0.6) paresthesia 8 (2) 10 (2.8) Systemic Reactions The most commonly encountered acute adverse experiences that demand immediate countermeasures are related to the central nervous system and the cardiovascular system. These adverse experiences are generally dose-related and due to high plasma levels that may result from overdosage, rapid absorption from the injection site, diminished tolerance or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional subarachnoid injection of drug during the intended performance of lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) may result in underventilation or apnea ( Total or High Spinal ). Also, hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia may occur. This may lead to secondary cardiac arrest if untreated. Factors influencing plasma protein binding, such as acidosis, systemic diseases that alter protein production or competition with other drugs for protein binding sites, may diminish individual tolerance. Epidural administration of ropivacaine hydrochloride has, in some cases, as with other local anesthetics, been associated with transient increases in temperature to> 38.5 C. This occurred more frequently at doses of ropivacaine hydrochloride >16 mg/h. Neurologic Reactions These are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision or tremors may occur, possibly proceeding to convulsions. However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. Other central nervous system effects may be nausea, vomiting, chills, and constriction of the pupils. The incidence of convulsions associated with the use of local anesthetics varies with the route of administration and the total dose administered. In a survey of studies of epidural anesthesia, overt toxicity progressing to convulsions occurred in approximately 0.1% of local anesthetic administrations. The incidence of adverse neurological reactions associated with the use of local anesthetics may be related to the total dose and concentration of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the drug. During lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter or needle may occur. Subsequent adverse effects may depend partially on the amount of drug administered intrathecally as well as the physiological and physical effects of a dural puncture. These observations may include spinal block of varying magnitude (including high or total spinal block), hypotension secondary to spinal block, urinary retention, loss of bladder and bowel control (fecal and urinary incontinence), and loss of perineal sensation and sexual function. Signs and symptoms of subarachnoid block typically start within 2 to 3 minutes of injection. Doses of 15 and 22.5 mg of ropivacaine hydrochloride resulted in sensory levels as high as T5 and T4, respectively. Analgesia started in the sacral dermatomes in 2 to 3 minutes and extended to the T10 level in 10 to 13 minutes and lasted for approximately 2 hours. Other neurological effects following unintentional subarachnoid administration during epidural anesthesia may include persistent anesthesia, paresthesia, weakness, paralysis of the lower extremities, and loss of sphincter control; all of which may have slow, incomplete or no recovery. Headache, septic meningitis, meningismus, slowing of labor, increased incidence of forceps delivery, or cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid have been reported (see DOSAGE AND ADMINISTRATION discussion of Lumbar Epidural Block). A high spinal is characterized by paralysis of the arms, loss of consciousness, respiratory paralysis and bradycardia. Cardiovascular System Reactions High doses or unintentional intravascular injection may lead to high plasma levels and related depression of the myocardium, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation, and possibly cardiac arrest (see WARNINGS , PRECAUTIONS , and OVERDOSAGE ). Allergic Reactions Allergic type reactions are rare and may occur as a result of sensitivity to the local anesthetic (see WARNINGS ). These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid symptomatology (including severe hypotension). Cross-sensitivity among members of the amide-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitively established. Overdosage Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution (see ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ). MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES Therapy with ropivacaine hydrochloride should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with ropivacaine hydrochloride; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of ropivacaine hydrochloride, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient s state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, non-pregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5 mcg/mL, respectively. In human volunteers given intravenous ropivacaine hydrochloride, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4 to 5.3) and 0.6 (0.3 to 0.9) mcg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of non-pregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts. Ropivacaine Injection Dosage and Administration The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should always be used. The smallest dose and concentration required to produce the desired result should be administered. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Ropivacaine hydrochloride injection is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention although regional anesthesia is frequently indicated in these patients. To reduce the risk of potentially serious adverse reactions, attempts should be made to optimize the patient s condition before major blocks are performed, and the dosage should be adjusted accordingly. Use an adequate test dose (3 mL to 5 mL of a short acting local anesthetic solution containing epinephrine) prior to induction of complete block. This test dose should be repeated if the patient is moved in such a fashion as to have displaced the epidural catheter. Allow adequate time for onset of anesthesia following administration of each test dose. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Solutions which are discolored or which contain particulate matter should not be administered. The doses in the table are those considered to be necessary to produce a successful block and should be regarded as guidelines for use in adults. Individual variations in onset and duration occur. The figures reflect the expected average dose range needed. For other local anesthetic techniques standard current textbooks should be consulted. When prolonged blocks are used, either through continuous infusion or through repeated bolus administration, the risks of reaching a toxic plasma concentration or inducing local neural injury must be considered. Experience to date indicates that a cumulative dose of up to 770 mg ropivacaine hydrochloride injection administered over 24 hours is well tolerated in adults when used for postoperative pain management: i.e., 2016 mg. Caution should be exercised when administering ropivacaine hydrochloride injection for prolonged periods of time, e.g., >70 hours in debilitated patients. For treatment of postoperative pain, the following technique can be recommended: If regional anesthesia was not used intraoperatively, then an initial epidural block with 5 mL to 7 mL ropivacaine hydrochloride injection is induced via an epidural catheter. Analgesia is maintained with an infusion of ropivacaine hydrochloride injection, 2 mg/mL (0.2%). Clinical studies have demonstrated that infusion rates of 6 mL to 14 mL (12 mg to 28 mg) per hour provide adequate analgesia with nonprogressive motor block. With this technique a significant reduction in the need for opioids was demonstrated. Clinical experience supports the use of ropivacaine hydrochloride epidural infusions for up to 72 hours. Table 7 Dosage Recommendations * = Not Applicable = The dose for a major nerve block must be adjusted according to site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used (see PRECAUTIONS ). = Median dose of 21 mg per hour was administered by continuous infusion or by incremental injections (top-ups) over a median delivery time of 5.5 hours. = Cumulative doses up to 770 mg of ropivacaine hydrochloride over 24 hours (intraoperative block plus postoperative infusion); Continuous epidural infusion at rates up to 28 mg per hour for 72 hours have been well tolerated in adults, i.e., 2016 mg plus surgical dose of approximately 100 mg to 150 mg as top-up. Conc. Volume mL Dose mg Onset min Duration hours mg/mL (%) SURGICAL ANESTHESIA Lumbar Epidural 5 (0.5%) 15 to 30 75 to 150 15 to 30 2 to 4 Administration 7.5 (0.75%) 15 to 25 113 to 188 10 to 20 3 to 5 Surgery 10 (1%) 15 to 20 150 to 200 10 to 20 4 to 6 Lumbar Epidural 5 (0.5%) 20 to 30 100 to 150 15 to 25 2 to 4 Administration 7.5 (0.75%) 15 to 20 113 to 150 10 to 20 3 to 5 Cesarean Section Thoracic Epidural 5 (0.5%) 5 to 15 25 to 75 10 to 20 n/a * Administration Surgery 7.5 (0.75%) 5 to 15 38 to 113 10 to 20 n/a * Major Nerve Block 5 (0.5%) 35 to 50 175 to 250 15 to 30 5 to 8 (e.g., brachial plexus block) 7.5 (0.75%) 10 to 40 75 to 300 10 to 25 6 to 10 Field Block 5 (0.5%) 1 to 40 5 to 200 1 to 15 2 to 6 (e.g., minor nerve blocks and infiltration) LABOR PAIN MANAGEMENT Lumbar Epidural Administration Initial Dose 2 (0.2%) 10 to 20 20 to 40 10 to 15 0.5 to 1.5 Continuous infusion 2 (0.2%) 6 to 14 mL/h 12 to 28 mg/h n/a * n/a * Incremental injections (top-up) 2 (0.2%) 10 to 15 mL/h 20 to 30 mg/h n/a * n/a * POSTOPERATIVE PAIN MANAGEMENT Lumbar Epidural Administration Continuous infusion 2 (0.2%) 6 to 14 mL/h 12 to 28 mg/h n/a * n/a * Thoracic Epidural Administration 2 (0.2%) 6 to 14 mL/h 12 to 28 mg/h n/a* n/a * Continuous infusion Infiltration 2 (0.2%) 1 to 100 2 to 200 1 to 5 2 to 6 (e.g., minor nerve block) 5 (0.5%) 1 to 40 5 to 200 1 to 5 2 to 6 How is Ropivacaine Injection Supplied Ropivacaine hydrochloride injection, USP is a clear, colorless, sterile, isotonic solution free from visible particles and is supplied as follows: Ropivacaine hydrochloride injection USP, 0.2 % 40 mg/20 mL (2 mg/mL): 20 mL Single Dose Vials in a Carton of 25 NDC 55150-195-20 200 mg/100 mL (2 mg/mL): 100 mL Single Dose Infusion Bottles Packaged Individually NDC 55150-196-99 Ropivacaine hydrochloride injection USP, 0.5 % 100 mg/20 mL (5 mg/mL): 20 mL Single Dose Vials in a Carton of 25 NDC 55150-197-20 150 mg/30 mL (5 mg/mL): 30 mL Single Dose Vials in a Carton of 25 NDC 55150-198-30 Ropivacaine hydrochloride injection USP, 0.75 % 150 mg/20 mL (7.5 mg/mL): 20 mL Single Dose Vials in a Carton of 25 NDC 55150-199-20 Ropivacaine hydrochloride injection USP, 1 % 100 mg/10 mL (10 mg/mL): 10 mL Single Dose Vials in a Carton of 25 NDC 55150-200-10 200 mg/20 mL (10 mg/mL): 20 mL Single Dose Vials in a Carton of 25 NDC 55150-201-20 The solubility of ropivacaine is limited at pH above 6. Thus, care must be taken as precipitation may occur if ropivacaine hydrochloride injection, USP is mixed with alkaline solutions. Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection since they have been related to incidents of swelling and edema. When chemical disinfection of the container surface is desired, either isopropyl alcohol (91%) or ethyl alcohol (70%) is recommended. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use. Glass containers may, as an alternative, be autoclaved once. Stability has been demonstrated using a targeted F 0 of 7 minutes at 121 C. Solutions should be stored at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. The vial stoppers are not made with natural rubber latex. These products are intended for single use and are free from preservatives. Any solution remaining from an opened container should be discarded promptly. In addition, continuous infusion bottles should not be left in place for more than 24 hours. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: March 2017 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2 mg/mL) - 20 mL Container Label Rx only NDC 55150-195-20 Ropivacaine 0.2% Hydrochloride Injection, USP 40 mg/20 mL (2 mg/mL) For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Administration. 20 mL Single Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2 mg/mL) - 20 mL Container-Carton (25 Vials) Rx only NDC 55150-195-20 Ropivacaine 0.2% Hydrochloride Injection, USP 40 mg/20 mL (2 mg/mL) For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Administration. Sterile 25 x 20 mL Nonpyrogenic Single Dose Vials AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2 mg/mL) - 100 mL Container Label Rx only NDC 55150-196-99 Ropivacaine 0.2% Hydrochloride Injection, USP 200 mg/100 mL (2 mg/mL) For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Administration. For continuous infiltration or epidural infusion only. 100 mL Single Dose Infusion Bottle PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2 mg/mL) - 100 mL Container-Carton (1 Vial) Rx only NDC 55150-196-99 Ropivacaine 0.2% Hydrochloride Injection, USP 200 mg/100 mL (2 mg/mL) For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Administration. For continuous infiltration or epidural infusion only. 100 mL Single Dose Infusion Bottle AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.5% (5 mg/mL) - 20 mL Container Label Rx only NDC 55150-197-20 Ropivacaine 0.5% Hydrochloride Injection, USP 100 mg/20 mL (5 mg/mL) For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Administration. 20 mL Single Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.5% (5 mg/mL) - 20 mL Container-Carton (25 Vials) Rx only NDC 55150-197-20 Ropivacaine 0.5% Hydrochloride Injection, USP 100 mg/20 mL (5 mg/mL) For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Administration. Sterile 25 x 20 mL Nonpyrogenic Single Dose Vials AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.5% (5 mg/mL) - 30 mL Container Label Rx only NDC 55150-198-30 Ropivacaine 0.5% Hydrochloride Injection, USP 150 mg/30 mL (5 mg/mL) For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Administration. 30 mL Single Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.5% (5 mg/mL) - 30 mL Container-Carton (25 Vials) Rx only NDC 55150-198-30 Ropivacaine 0.5% Hydrochloride Injection, USP 150 mg/30 mL (5 mg/mL) For Infiltration, Nerve Block, and Epidural Administration Only. Not for Intravenous Administration. Sterile 25 x 30 mL Nonpyrogenic Single Dose Vials AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.75% (7.5 mg/mL) - 20 mL Container Label Rx only NDC 55150-199-20 Ropivacaine 0.75% Hydrochloride Injection, USP 150 mg/20 mL (7.5 mg/mL) For Nerve Block and Epidural Administration Only. Not for Intravenous Administration. 20 mL Single Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.75% (7.5 mg/mL) - 20 mL Container-Carton (25 Vials) Rx only NDC 55150-199-20 Ropivacaine 0.75% Hydrochloride Injection, USP 150 mg/20 mL (7.5 mg/mL) For Nerve Block and Epidural Administration Only. Not for Intravenous Administration. Sterile 25 x 20 mL Nonpyrogenic Single Dose Vials AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-1% (10 mg/mL) - 10 mL Container Label Rx only NDC 55150-200-10 Ropivacaine 1% Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL) For Epidural Administration Only. Not for Intravenous Administration. 10 mL Single Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-1% (10 mg/mL) - 10 mL Container-Carton (25 Vials) Rx only NDC 55150-200-10 Ropivacaine 1% Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL) For Epidural Administration Only. Not for Intravenous Administration. Sterile 25 x 10 mL Nonpyrogenic Single Dose Vials AUROMEDICS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-1% (10 mg/mL) - 20 mL Container Label Rx only NDC 55150-201-20 Ropivacaine 1% Hydrochloride Injection, USP 200 mg/20 mL (10 mg/mL) For Epidural Administration Only. Not for Intravenous Administration. 20 mL Single Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-1% (10 mg/mL) - 20 mL Container-Carton (25 Vials) Rx only NDC 55150-201-20 Ropivacaine 1% Hydrochloride Injection, USP 200 mg/20 mL (10 mg/mL) For Epidural Administration Only. Not for Intravenous Administration. Sterile 25 x 20 mL Nonpyrogenic Single Dose Vials AUROMEDICS ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55150-195 Route of Administration INFILTRATION, PERINEURAL, EPIDURAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE) ROPIVACAINE HYDROCHLORIDE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:55150-195-20 25 VIAL, SINGLE-DOSE in 1 CARTON 1 20 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205612 09/15/2016 ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55150-196 Route of Administration INFILTRATION, PERINEURAL, EPIDURAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE) ROPIVACAINE HYDROCHLORIDE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:55150-196-99 1 BOTTLE, GLASS in 1 CARTON 1 100 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205612 09/15/2016 ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55150-197 Route of Administration INFILTRATION, PERINEURAL, EPIDURAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE) ROPIVACAINE HYDROCHLORIDE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:55150-197-20 25 VIAL, SINGLE-DOSE in 1 CARTON 1 20 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205612 09/15/2016 ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55150-198 Route of Administration INFILTRATION, PERINEURAL, EPIDURAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE) ROPIVACAINE HYDROCHLORIDE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:55150-198-30 25 VIAL, SINGLE-DOSE in 1 CARTON 1 30 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205612 09/15/2016 ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55150-199 Route of Administration PERINEURAL, EPIDURAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE) ROPIVACAINE HYDROCHLORIDE 7.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:55150-199-20 25 VIAL, SINGLE-DOSE in 1 CARTON 1 20 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205612 09/15/2016 ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55150-200 Route of Administration EPIDURAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE) ROPIVACAINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:55150-200-10 25 VIAL, SINGLE-DOSE in 1 CARTON 1 10 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205612 09/15/2016 ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55150-201 Route of Administration EPIDURAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROPIVACAINE HYDROCHLORIDE (ROPIVACAINE) ROPIVACAINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:55150-201-20 25 VIAL, SINGLE-DOSE in 1 CARTON 1 20 mL in 1 VIAL, SINGLE-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205612 09/15/2016 Labeler - AuroMedics Pharma LLC (968961354) Establishment Name Address ID/FEI Operations Aurobindo Pharma Limited 650498244 ANALYSIS(55150-195, 55150-196, 55150-197, 55150-198, 55150-199, 55150-200, 55150-201), MANUFACTURE(55150-195, 55150-196, 55150-197, 55150-198, 55150-199, 55150-200, 55150-201) Revised: 06/2017 AuroMedics Pharma LLC Next Interactions Print this page Add to My Med List More about ropivacaine Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Compare Alternatives Support Group Pricing & Coupons En Español 1 Review Add your own review/rating Drug class: local injectable anesthetics Consumer resources Ropivacaine Ropivacaine Injection (Advanced Reading) Professional resources Ropivacaine (Wol family member
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